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BGF MDI (PT010)
BGF MDI is a triple-combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist that reduces airway inflammation and improves bronchodilation in chronic obstructive pulmonary disease.
BGF MDI is a triple-combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist that reduces airway inflammation and improves bronchodilation in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | BGF MDI (PT010) |
|---|---|
| Also known as | BGF |
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Triple-combination inhaler (ICS/LABA/LAMA) |
| Target | Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines budesonide (ICS) to suppress airway inflammation, formoterol (LABA) to provide rapid and sustained bronchodilation via beta-2 receptor agonism, and glycopyrronium (LAMA) to provide additional bronchodilation through muscarinic receptor antagonism. This triple therapy addresses multiple pathophysiologic mechanisms in COPD to improve lung function and reduce exacerbations.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Dysphonia
Key clinical trials
- Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (PHASE3)
- Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (PHASE3)
- Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PHASE3)
- A Scintigraphy Study of PT010 in COPD Patients (PHASE1)
- Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos) (PHASE3)
- Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects (PHASE1)
- A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (PHASE3)
- A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |